Primary Liver CancerNCT03297255
Primary Liver Cancer Cohort of South China
An observational study of Primary Liver Cancer, run by Huilian Zhu at 1 site in China.
Trial summary
This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer. Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score, Child-Pugh score, and BCLC stage) were collected by… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Liver Cancer
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of this study were invited from Sun Yat-sen University Cancer Center as soon as they were diagnosed as primary liver cancer
Who may be able to join
- age 18-80 years
- consistent with primary liver cancer diagnostic criteria
- first diagnosis (from diagnosis to admission interval of less than a month)
- did not do any treatment of liver cancer
Who cannot join
- refused to participate in this study
- suffering from more than two kinds of primary tumors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Chen Minshan, Professor, +86 20 87343117, chenmsh@sysucc.org.cn
About this study
Official title: Factors Influencing the Occurrence and Long-term Survival of Patients With Primary Liver Cancer: A Cohort Study in South China
This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer. Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score, Child-Pugh score, and BCLC stage) were collected by professional doctors. Clinical outcomes (death, recurrence, and metastasis) will be followed up every two years after therapy.
Read the detailed description
Primary liver cancer (PLC) is highly malignant with high mortality which is particularly popular in China. Many factors are believed to associate with the occurrence and prognosis of liver cancer. This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer.
- Conditions
- Primary Liver Cancer
- Keywords
- Primary Liver Cancer; Cohort Study
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Death
The exact death time of each participants will be checked in the government medical records system
Measured: Up to 10 years
Secondary outcomes (2)
Time of recurrence
Time of recurrence will be obtained by telephone interview or medical treatment records
Measured: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years
Time of metastasis
Time of metastasis will be obtained by telephone interview or medical treatment records
Measured: From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Jan 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huilian Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huilian Zhu, Sun Yat-sen University
- Investigators
- Zhu Huilian, Professor, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297255
- Sponsor's protocol ID
- SYS-2013
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
Publications
Liu ZY, Yishake D, Fang AP, Zhang DM, Liao GC, Tan XY, Zhang YJ, Zhu HL. Serum choline is associated with hepatocellular carcinoma survival: a prospective cohort study. Nutr Metab (Lond). 2020 Mar 30;17:25. doi: 10.1186/s12986-020-00445-z. eCollection 2020.
PubMed 32256673Liu ZY, Tan XY, Li QJ, Liao GC, Fang AP, Zhang DM, Chen PY, Wang XY, Luo Y, Long JA, Zhong RH, Zhu HL. Trimethylamine N-oxide, a gut microbiota-dependent metabolite of choline, is positively associated with the risk of primary liver cancer: a case-control study. Nutr Metab (Lond). 2018 Nov 20;15:81. doi: 10.1186/s12986-018-0319-2. eCollection 2018.
PubMed 30479648
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Occurrence and Long-term Survival of Patients With Primary Liver Cancer: A Cohort Study in South China
- ClinicalTrials.gov ID
- NCT03297255
- Acronym / sponsor ID
- SYS-2013
- Conditions
- Primary Liver Cancer
- Keywords
- Primary Liver Cancer; Cohort Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Huilian ZhuUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer. Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score, Child-Pugh score, and BCLC stage) were collected by professional doctors. Clinical outcomes (death, recurrence, and metastasis) will be followed up every two years after therapy.
Detailed description
Primary liver cancer (PLC) is highly malignant with high mortality which is particularly popular in China. Many factors are believed to associate with the occurrence and prognosis of liver cancer. This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of this study were invited from Sun Yat-sen University Cancer Center as soon as they were diagnosed as primary liver cancer
Key inclusion criteria (4 listed)
- age 18-80 years
- consistent with primary liver cancer diagnostic criteria
- first diagnosis (from diagnosis to admission interval of less than a month)
- did not do any treatment of liver cancer
Key exclusion criteria (2 listed)
- refused to participate in this study
- suffering from more than two kinds of primary tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time of Death
Time frame: Up to 10 years
The exact death time of each participants will be checked in the government medical records system
2 secondary outcomes
Time of recurrence
Time frame: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years
Time of metastasis
Time frame: From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Derived from this study: PubMed 32256673Liu ZY, Yishake D, Fang AP, Zhang DM, Liao GC, Tan XY, Zhang YJ, Zhu HL. Serum choline is associated with hepatocellular carcinoma survival: a prospective cohort study. Nutr Metab (Lond). 2020 Mar 30;17:25. doi: 10.1186/s12986-020-00445-z. eCollection 2020.
- Derived from this study: PubMed 30479648Liu ZY, Tan XY, Li QJ, Liao GC, Fang AP, Zhang DM, Chen PY, Wang XY, Luo Y, Long JA, Zhong RH, Zhu HL. Trimethylamine N-oxide, a gut microbiota-dependent metabolite of choline, is positively associated with the risk of primary liver cancer: a case-control study. Nutr Metab (Lond). 2018 Nov 20;15:81. doi: 10.1186/s12986-018-0319-2. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhu Huilian, Professor study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Liver Cancer, run by Huilian Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhu Huilian, Professor (+86 20 87331811, zhuhl@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of Death (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297255, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.